MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT

K081351 · Smith & Nephew, Inc. · HSX · Jul 24, 2008 · Orthopedic

Device Facts

• Record ID: K081351
• Device Name: MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
• Applicant: Smith & Nephew, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: Jul 24, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Journey Unicondylar Knee System is indicated for restoring either compartment of a knee that has been affected by the following: 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Correction of functional deformity; 3. Revision procedures where other treatments or devices have failed; and 4. Treatment of fractures that are unmanageable using other techniques. The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.

Device Story

Journey Unicondylar Femoral Implant is a metallic prosthetic component for unicompartmental knee arthroplasty. Device replaces damaged femoral articular surfaces in medial or lateral tibiofemoral compartments. Implants are manufactured in Cobalt Chrome or Oxidized Zirconium (OXINIUM) in sizes 1-7. Device is intended for use with bone cement and compatible with specific third-party tibial baseplates and polyethylene inserts. Used by orthopedic surgeons in clinical/surgical settings to restore joint function, correct deformities, or address fractures/failed prior procedures. Benefits include restoration of knee joint mechanics and pain relief for patients with degenerative joint disease.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design control activities and comparison of technological characteristics to previously cleared predicate devices.

Technological Characteristics

Materials: Cobalt Chrome and Oxidized Zirconium (OXINIUM) alloy. Form factor: Unicondylar femoral component, sizes 1-7. Fixation: Cemented. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring restoration of a knee compartment due to noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), functional deformity, failed prior treatments, or unmanageable fractures. For single-use, cemented implantation.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• Journey Unicondylar Femoral Implants (K073175)
• GENESIS Unicompartmental Knee System (K912735)
• Unicondylar Femoral Component (K030301)
• Unicompartmental Knee System (K033363)

Reference Devices

• Competitor Unicondylar All-Poly Tibial Baseplates (K061779)
• Competitor Unicondylar Knee Tibial Baseplates and Polyethylene Inserts (K061011)

Submission Summary (Full Text)

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JUL 2 4 2008

Kori351

# 510(K) Summary Smith & Nephew Smith & Nephew Journey Unicondylar Femoral Implant

| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|-----------------------------------|-------------------------------------------------------------------------------------------------|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6017 |
| CONTACT PERSON: | Nicholas B. Tabrizi |
| DATE SUMMARY PREPARED: | May 2, 2008 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew Journey Unicondylar Femoral Implant |
| COMMON OR USUAL NAME: | Unicompartmental Knee Prosthesis |
| CLASSIFICATION NAME: | Knee joint femorotibial metal/polymer semi constrained cemented<br>prosthesis, 21 CFR 8888.3520 |
| DEVICE CLASS: | Class II |
| PANEL CODE: | Orthopaedics/87/HSX |

#### A. INTENDED USE:

The Journey Unicondylar Knee System is indicated for restoring either compartment of a knee that has been affected by the following:

- 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Correction of functional deformity; 2.
- ల్లా Revision procedures where other treatments or devices have failed; and
- 4. Treatment of fractures that are unmanageable using other techniques.

The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.

#### B. DEVICE DESCRIPTION:

The devices, subject of this Premarket Notification, are the Smith & Nephew, Inc. Journey Unicondylar Femoral Implant components. The Journey unicondylar femoral implants are intended for cemented medial and lateral tibiofemoral replacement. The femoral implants will be offered in both Cobalt Chrome and Oxidized Zirconium alloy (OXINIUM) materials in sizes 1 through 7. The Smith & Nephew Journey Unicondylar femoral components feature the same articular surface geometry as existing femoral implants cleared in K073175.

The Journey Unicondylar femoral components are intended to be used in combination with the Competitor Unicondvlar All-Poly Tibial Baseplates IK061779), or the Competitor Unicondylar Knee Tibial Baseplates and Polyethylene Inserts {K061011}.

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## ﻥ SUBSTANTIAL EQUIVALENCE INFORMATION:

The Smith & Nephew Journey Unicondylar Femoral Implant is similar to the following commercially available devices regarding design features, overall indications, and materials:

| Manufacturer | Description | Submission<br>Number | Clearance<br>Date |
|----------------------|--------------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | Journey Unicondylar Femoral Implants | K073175 | 12/28/2007 |
| Smith & Nephew, Inc. | GENESIS Unicompartmental Knee System | K912735 | 12/27/1991 |
| Smith & Nephew, Inc. | Unicondylar Femoral Component | K030301 | 02/25/2003 |
| Zimmer, Inc. | Unicompartmental Knee System | K033363 | 01/10/2004 |

## D. SUMMARY OF TECHNOLOGICAL COMPARISON:

The intended use, design, and materials of the Journey Unicondylar Femoral Implants are substantially equivalent to the previously cleared Journey Unicondylar Femoral Implants (K073175). Design Control Activities have been completed and the results indicated that the subject device is safe and effective.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. Orthopaedic Division % Mr. Nicholas B. Tabrizi 1450 East Brooks Road Memphis, TN 38116

JUL 2 4 2008

K081351 Trade/Device Name: Smith & Nephew Journey Unicondylar Femoral Implant Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prothesis Regulatory Class: Class II Product Code: HSX Dated: June 24, 2008 Received: July 1, 2008

Dear Mr. Tabrizi:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Nicholas B. Tabrizi

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Miller

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: Smith & Nephew Journey Unicondylar Femoral Implant

Indications for Use:

The Journey Unicondylar Knee System is indicated for restoring either compartment of a knee that has been affected by the following:

- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1. avascular necrosis;
- 2. Correction of functional deformity;
- 3. Revision procedures where other treatments or devices have failed; and
- 4. Treatment of fractures that are unmanageable using other techniques.

The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.

x Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

(Division Sigr Division of General, Restorative, and Neurological Devices

**510(k) Number** K081351